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美国疫苗伤害补偿制度研究及对我国的启示 Δ

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王艺芳 ，杨 悦 （1.沈阳药科大学工商管理学院，沈阳 110016；2.沈阳药科大学国际食品药品政策与法律
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研究中心，沈阳 110016）

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）10-1158-08
DOI 10.6039/j.issn.1001-0408.2020.10.02

摘 要 目的：为建立和完善我国疫苗接种异常反应补偿制度提供参考。方法：采用文献研究的分析方法，全面梳理美国疫苗伤
害补偿计划（VICP）的建立背景、制度要素（包括管理体系、筹资模式、补偿范围、补偿申请条件、补偿费用类型及标准）、运行机制
（包括补偿申请的诉讼参与方、《疫苗伤害表》列表内与列表外伤害两种因果关系判定路径、补偿申请的诉讼程序），评价其实施成
效、障碍及不足，并对我国相应补偿制度的建立和完善提出建议。结果与结论：美国VICP的管理体系由美国卫生与公众服务部
（HHS）、美国联邦索赔法院和美国司法部三大职能部门组成；VICP采取专项基金补偿模式，向疫苗企业征收疫苗消费税来建立疫
苗伤害补偿信托基金，并通过建立和不断修订《疫苗伤害表》以及补偿申请等程序，结合其司法体系的审判优势，为疫苗受害者提
供了一套完整的“无过错”补偿机制。VICP虽存在补偿时间超过预期、《疫苗伤害表》修订标准模糊等障碍与不足，但其实现了充
分补偿疫苗受害者和促进疫苗企业有效供应疫苗的双重立法目标。借鉴美国VICP的经验，并基于我国《疫苗管理法》第五十六条
的规定，建议从探索建立基金补偿模式、委托第三方提供补偿服务、落实补偿目录及其调整机制、重置补偿申请程序、建立目录内
和目录外两条补偿路径、科学设定补偿标准等6个方面入手，建立和完善我国疫苗接种异常反应补偿制度，维护公众接种信心。
关键词 美国；疫苗伤害补偿计划；疫苗接种异常反应；补偿基金；疫苗管理法；启示

Study on Vaccine Injury Compensation Program in the United States and Its Enlightenments for China
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WANG Yifang ，YANG Yue （1. School of Business Administration，Shenyang Pharmaceutical University，
Shenyang 110016，China；2. International Food & Drug Policy and Law Research Center，Shenyang
Pharmaceutical University，Shenyang 110016，China）

ABSTRACT OBJECTIVE：To provide reference for establishing and improving the compensation system for vaccination
abnormal reaction in China. METHODS：By adopting the method of literature research，the background，institutional elements
（including management system，financing mode，compensation scope，compensation application conditions，compensation expense
type and standard）and operation mechanism（including the litigation participants of compensation application，the judgment path
of causality between injuries in and out of the list of Vaccine Injury Table，and the litigation procedure of compensation
application） of Vaccine Injury Compensation Program （VICP） in the United States were summarized comprehensively. Its
implementation performance，obstacle and deficiencies were evaluated，and suggestions were put forward for the establishment and
improvement corresponding compensation system in China. RESULTS & CONCLUSIONS：VICP management system of the
United States composed of the U.S. Department of Health and Human Services（HHS），the U.S. Federal Claims Court，and the U.
S. Department of Justice. VICP adopts special fund compensation mode，and vaccine consumption tax is levied on vaccine
enterprises to establish a vaccine injury compensation trust fund；through the establishment and continuous revision of Vaccine
Injury Table，compensation application and other procedures，combined with the trial advantages of its judicial system，a complete
set of “no fault” compensation mechanism is provided for vaccine victims. There were obstacle and deficiency such as
compensation time out of expectation，obscure revision standard of Vaccine Injury Table in VICP，but it achieved the dual
legislative goals of fully compensating vaccine victims and promoted the effective supply of vaccines by vaccine enterprises.
Drawing on the experience of VICP in the United States，and based on the provisions of Article 56 of the Vaccine Administration
Law of China，it is suggested to establish and improve the compensation system for vaccination abnormal reaction in China and
maintain the public’s confidence in vaccination from six aspects，i.e. exploring the establishment of fund compensation mode，
entrusting a third party to provide compensation services，implementing the compensation catalogue and its adjustment mechanism，
resetting the compensation application procedure，establishing two compensation paths within and outside the catalogue，and
scientifically setting compensation standards.
Δ 基金项目：国家市场监督管理总局 2019 年度政策研究课
KEYWORDS United States；Vaccine Injury Compen-
题——“药品安全监管的国际经验借鉴”
sation Program；Vaccination adverse reaction；Compensa-
＊硕士研究生。研究方向：药品政策、药事法规。E-mail：yf-
wang78@163.com tion fund；Vaccine administration law；Enlightenment
# 通信作者：教授，博士生导师，博士。研究方向：药品政策、药事
法规。电话：024-23986372。E-mail：yyue315@vip.126.com

·1158 · China Pharmacy 2020 Vol. 31 No. 10 中国药房 2020年第31卷第10期